Events

Rappel de Device Recall BD BBL (tm) LowensteinJensen Medium Deeps

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Becton Dickinson & Co..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61170
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1322-2012
  • Date de mise en oeuvre de l'événement
    2012-01-30
  • Date de publication de l'événement
    2012-03-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107453
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, blood culturing - Product Code MDB
  • Cause
    Media fails to perform as intended with quality control organism mycobacterium kansasii.
  • Action
    The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated January 2012 to Ex-US BD sites via email and its customers via UPS ground shipment on 1/30/12. The letter identified the product, the problem and the action to be taken. The customers were instructed to discontinue use of the recalled lot numbers and discard any remaining packages. Customers were also instructed to complete and return the attached form whether or not they had any inventory remaining via fax to: BD Regulatory Compliance at 410-316-4285. The letter also informed the customers that BD has decided to discontinue this product. If further assistance is needed regarding credit, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BD BBL (tm) LowensteinJensen Medium Deeps
  • Modèle / numéro de série
    Catalog #221257, Lot 0091498 Exp. 10/6/11, Lot 0224698 Exp. 2/16/12, Lot 0301803 Exp. 5/3/1112, Lot 1055386 Exp. 8/30/12, Lot 1167837 Exp. 12/20/12
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including states of: AL, CA, CT, IA, IL, KY, LA, MD, MI, MN, NC, NJ, NY, OH, PA, TN, VA, WA, and WV; and countries of : Belgium and Singapore.
  • Description du dispositif
    BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as deeps is used for the semi-quantitative catalase test as an aid to the classification of mycobacteria.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA